Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)

NCT ID: NCT00743574

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2013-02-28

Brief Summary

The investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium (Ca) supplementation in overweight (BMI > 27) premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and who were deficient in vitamin D as reflected by serum 25-hydroxy (25-OH) vitamin D (serum levels < 20 ng/mL).

Detailed Description

We had hypothesized that in women with PCOS, administering optimal daily doses of vitamin D3, as recommended by the National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of calcium, both per oral (PO), over a three month period will improve their metabolic picture, and possibly hormone profile.

Over the course of the trial, after the first 5 subjects had completed 3 month intervention,we observed that daily 2000IU D3 dosing regime was inadequate in normalizing vitamin D status in the study population; the dosing regimen was therefore modified to include weekly supplementation with 50,000IU D2 in addition to daily dosing with 2000IU D3.

Conditions

Polycystic Ovarian Syndrome; Vitamin D Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D plus Calcium (Ca) supplementation

Group Type: EXPERIMENTAL

Vitamin D2 (Ergocalciferol)

Intervention Type: DIETARY_SUPPLEMENT

50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)

Medroxyprogesterone (Provera)

Intervention Type: DRUG

10mg, PO, daily for ten days

Vitamin D3 (Cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

2,000IU (or 2 tablets), PO, daily (supplements taken for three months)

Elemental Calcium

Intervention Type: DIETARY_SUPPLEMENT

1,000mg (or 2 tablets), PO, daily (supplements taken for three months)

Interventions

Vitamin D2 (Ergocalciferol)

50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)

Intervention Type: DIETARY_SUPPLEMENT

Medroxyprogesterone (Provera)

10mg, PO, daily for ten days

Intervention Type: DRUG

Vitamin D3 (Cholecalciferol)

2,000IU (or 2 tablets), PO, daily (supplements taken for three months)

Intervention Type: DIETARY_SUPPLEMENT

Elemental Calcium

1,000mg (or 2 tablets), PO, daily (supplements taken for three months)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Premenopausal women (ages 18-40 years) with normal thyroid function and prolactin levels.
• PCOS diagnosis based on Rotterdam criteria: presence of at least 2 of the following criteria:

• oligomenorrhea-menstrual cycles > 35 day intervals
• hyperandrogenemia (elevated serum testosterone [free or total] &/or androstenedione levels) or features of hyperandrogenism i.e. acne or hirsuitism [Ferriman-Gallaway score > 3]
• polycystic ovaries on vaginal ultrasound as defined by ESHRE/ASRM criteria (ovarian volume ≥ 10mL or ≥ 12 follicles of diameter between 2-9mm in at least one ovary)
• Overweight (BMI ≥ 27 Kg/m2)
• Biochemical evidence of Vitamin D insufficiency (i.e. serum 25 OHD levels < 20ng/mL)

Exclusion Criteria

• Pregnancy
• Known causes of oligomenorrhea other than PCOS, e.g. hypothyroidism/Cushing's Disease/late onset congenital adrenal hyperplasia (fasting 17-alphahydroxyprogesterone levels < 200ng/dL)
• Use of hormonal treatment (birth control pill/patch/depot medroxyprogesterone/medroxyprogesterone) within 3 months of the study onset.
• Use insulin sensitizers (metformin, sulfonylureas, TZDs, incretins) within 3 months of the study onset.
• Use of lipid lowering agents or medications known to influence insulin sensitivity (e.g. niacin, corticosteroids, beta blockers, calcium channel blockers, thiazide diuretics) or influence serum androgens (estrogen, anti-androgens, androgens) within 3 months of the study onset.
• Known history of renal calculi or current use of Calcium and Vitamin D supplements.
• Spanish Speaking.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lubna Pal, MBBS,MRCOG,MSc.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale-New Haven Hospital-Women's Center

New Haven, Connecticut, United States

Countries

United States

References

Pal L, Berry A, Coraluzzi L, Kustan E, Danton C, Shaw J, Taylor H. Therapeutic implications of vitamin D and calcium in overweight women with polycystic ovary syndrome. Gynecol Endocrinol. 2012 Dec;28(12):965-8. doi: 10.3109/09513590.2012.696753. Epub 2012 Jul 11.

Reference Type: RESULT

PMID: 22780885 (View on PubMed)

Nardell M, Chhabra A, Pal L. Excluded, not dismissed: enhancing benefit in clinical research. Contemp Clin Trials. 2013 Jan;34(1):70-3. doi: 10.1016/j.cct.2012.08.013. Epub 2012 Sep 7.

Reference Type: DERIVED

PMID: 22981957 (View on PubMed)

Other Identifiers

YCCI-CARE Grant #UL1RR024139

Identifier Type: -

Identifier Source: secondary_id

YaleU-0807003992

Identifier Type: -

Identifier Source: org_study_id